Country: Malta
Bahasa: Inggeris
Sumber: Malta Medicines Authority
LEVODROPROPIZINE
Dompe Farmaceutici SpA Via San Martino 12, 20122, Milan, Italy
R05DB27
LEVODROPROPIZINE 6 % (W/V)
ORAL DROPS, SOLUTION
LEVODROPROPIZINE 6 % (W/V)
POM
COUGH AND COLD PREPARATIONS
Withdrawn
2009-01-30
1 PACKAGE LEAFLET LEVOTUSS 60 MG/ML ORAL DROPS, SOLUTION R05DB27 LEVODROPROPIZINE COMPOSITION 100 ml of solution contain : Active ingredient : Levodropropizin 6 g Excipients: propylene glycol, xylitol, sodium saccharate, methyl-para-hydroxybenzoate, forest fruits aroma, anise aroma, anhydrous citric acid, purified water PHARMACEUTICAL FORM AND CONTENT Oral drops, solution LEVOTUSS 60 mg/ml oral drops, solution – 30 ml bottle (1 ml contains 20 drops) PHARMACOTHERAPEUTIC CLASS Preparations for cough and cold: sedatives of cough. MARKETING AUTHORIZATION HOLDER Dompé farmaceutici S.p.A. – Via San Martino, 12, 20122 Milano (Italy) MANUFACTURER OF THE FINISHED PRODUCT Dompé farmaceutici S.p.A.., Via Campo di Pile, 67100 L’Aquila (Italy) RESPONSIBLE FOR BATCH RELEASE Dompé farmaceutici S.p.A., Via Campo di Pile, 67100 L’Aquila (Italy) THERAPEUTIC INDICATIONS Symptomatic therapy of cough CONTRAINDICATIONS Hypersensitivity to the active ingredient or to any excipient. Avoid the administration of the drug in patients with bronchial hypersecretion and reduced mucociliary function (Kartagener syndrome, ciliary dyskinesia). Pregnancy and lactation (see “Special warnings”). PRECAUTIONS FOR USE The effect of the administration of the specialty to children younger than 24 months has not been studied completely and in any case the drug should be used with caution in such patients. 2 Caution is recommended in patients with severe renal failure (creatinine clearance < 35 ml/min). It being evident that the sensitivity to several drugs is altered in old patients, special caution is necessary when administering Levodropropizin to old patients. Caution is also recommended for the concomitant intake of sedative drugs in particularly sensitive subjects (see “Interactions”). INTERACTIONS Animal pharmacology studies have demonstrated that Levodropropizin does not potentiate the effect of substances acting on the nervous system (eg. benzodiazepines, alcohol, phenytoin, imipramine). In animals, Levodropropizin does not mod Baca dokumen lengkap
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levotuss 60 mg/ml oral drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 ml of solution contain : Active ingredient : Levodropropizin 6 g Excipients: see 6.1 3. PHARMACEUTICAL FORM Oral drops, solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic therapy of cough 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: 20 drops (corresponding to 60 mg) up to 3 times daily with at least 6-hour-intervals, unless differently prescribed from the physician. Children: up to 3 daily administrations with at least 6-hour-intervals, according to the following scheme: WEIGHT (KG) NO. OF DROPS/ ADMINISTRATION WEIGHT (KG) NO. OF DROPS/ ADMINISTRATION 7-10 3 29-31 10 11-13 4 32-34 11 14-16 5 35-37 12 17-19 6 38-40 13 20-22 7 41-43 14 23-25 8 44-46 15 26-28 9 more than 46 20 According to the opinion of the physician, the above dosages may be doubled up to a maximum of 20 drops 3 times daily. Drops must preferably be diluted in a half glass water. Treatment should be continued until cough disappears or according to the physician’s prescription. In any case, if after 2 weeks of therapy, cough is still present, it is advisable to discontinue treatment and ask for the physician’s advice. Indeed, cough is a symptom and its causal pathology should be studied and treated. 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredient or to any excipient. Avoid the administration of the drug in patients with bronchorrhea and reduced mucociliary function (Ka Baca dokumen lengkap